Orion Group Half-Year Financial Report 1-6/2021

On July 19, 2021 Orion Group reported that Half-Year Financial Report 1-6/2021 (Press release, Orion , JUL 19, 2021, View Source [SID1234584946])

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This is a summary of Orion’s Half-Year Financial Report 1-6/2021. The complete report is attached to this stock exchange release and is available at View Source

Net sales totalled EUR 524 million (EUR 572 million in 1–6/2020).
Operating profit was EUR 146 (181) million.
Profit before taxes was EUR 145 (180) million.
Equity ratio was 68% (65%).
ROCE before taxes was 36% (44%).
ROE after taxes was 32% (38%).
Basic earnings per share were EUR 0.82 (1.02).
Cash flow per share before financial items was EUR 0.53 (0.90).
The outlook for 2021 remains unchanged. Orion estimates that net sales in 2021 will be slightly lower than in 2020 (net sales in 2020 were EUR 1,078 million). Operating profit is estimated to be lower or clearly lower than in 2020 (operating profit in 2020 was EUR 280 million).

President and CEO Timo Lappalainen:
Orion’s operating profit excluding milestone payments on par with previous year

"2021 has marched on steadily despite the exceptional circumstances brought on by the COVID-19 pandemic. For Orion, this has meant continuing to focus on looking after the health and safety of our employees and ensuring production continuity, product availability and patient safety in ongoing clinical trials.

Orion’s net sales in January-June 2021 were EUR 524 (572) million and the company’s operating profit was EUR 146 (181) million. The anticipated decline in net sales and operating profit was mainly attributable to three factors: the milestone payments that were clearly smaller than in the comparison period, a drop in the sales of Dexdor and Simdax owing to the expiration of their product patent protection and the expiration of a significant distribution agreement for veterinary drugs last year. Nubeqa product net sales booked by Orion increased as strongly as expected. The Specialty Products unit’s net sales were at a good level on the whole, although they did decrease from the strong comparison period. In some product groups, the demand has been clearly weaker than normal. This owes itself to various restrictions relating to the COVID-19 pandemic, which have resulted in a reduced prevalence of seasonal illnesses as opposed to the norm and a dip in the number of medical appointments. These consequences of the pandemic also had a negative effect on the demand for the Easyhaler products. The Animal Health unit’s business developed vigorously in all markets due to new product launches and distribution agreements, among other things. On the whole, the unit’s net sales fell short of the comparison period because of the said expiration of a significant distribution agreement.

During the review period, we received positive news of our research and development projects, as Tessie, a veterinary drug developed by Orion, was recommended for marketing authorisation by the Committee for Medical Products for Veterinary Use (CVMP) of the European Medicines Agency (EMA) and Bonqat, another veterinary drug developed by Orion, received a marketing authorisation from the European Commission.

More good news came in from Orion’s digital therapies development projects, as the VIRPI trial, which examined the effects of utilising virtual reality therapy in the treatment of chronic low back pain, reported positive results in June.

In the review period, we decided to discontinue the development of a new dry powder inhaler and focus on developing the existing Easyhaler platform as well as improving competitiveness. The Easyhaler technology has been on the market for decades and is the subject of continued development.

The estimate concerning the completion of the Phase III ARASENS clinical trial on darolutamide with Bayer was updated in the review period, and the trial is currently expected to reach primary completion in the final quarter of 2021. Orion’s other key clinical development projects proceeded as expected in the review period.

The global pharmaceutical supply chains have functioned fairly well from Orion’s perspective throughout the pandemic, and so far we have not experienced any material disruptions or shortages. To our current knowledge, no disruptions or shortages are expected to affect the outlook for the rest of 2021 either. The risk associated with disturbances in global supply and logistics chains continues to be higher than usual, and we have taken various measures to mitigate it, such as increasing the stock levels of products, raw materials and supplies clearly above their long-term averages. Travel and other restrictions resulting from the pandemic have not caused labour shortages at Orion so far, and we have been able to carry out all maintenance procedures and scheduled production shutdowns as planned, even those requiring special expertise.
In the review period, we continued our determined work to achieve Orion’s strategic growth target and commenced preparations to expand our non-European operations to Australia and New Zealand, among other things. Last year, we expanded our operations to Singapore, Malaysia and Thailand, and operations in these countries have started as planned. We have also continued our systematic work to identify and evaluate targets for product and business acquisitions."

Outlook for 2021 (provided on 9 February 2021)

Orion estimates that net sales in 2021 will be slightly lower than in 2020
(net sales in 2020 were EUR 1,078 million).

Operating profit is estimated to be lower or clearly lower than in 2020
(operating profit in 2020 was EUR 280 million).

Webcast and conference call

A webcast and a conference call for analysts, investors and media will be held on Monday, 19 July 2021 at 13.30 EEST. The event will be held only online and by conference call.

A link to the live webcast will be available on Orion’s website at www.orion.fi/en/investors. A recording of the event will be available on the website later the same day.

Scandion Oncology announces that its President & CEO has bought 4,500 shares in Scandion Oncology

On July 19, 2021 Scandion Oncology A/S ("Scandion Oncology") reported that its President & CEO, Bo Rode Hansen, has bought additional 4,500 shares in Scandion Oncology resulting in a total holding on 40,400 shares in the Company (Press release, Scandion Oncology, JUL 19, 2021, View Source;ceo-has-bought-4-500-shares-in-scandion-oncology,c3387000 [SID1234584945]).

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OncXerna Therapeutics to Present at The LifeSci Partners Private Company Summer Symposium

On July 19, 2021 OncXerna Therapeutics, Inc. ("OncXerna"), a precision medicine company using an innovative RNA-expression based biomarker platform to predict patient responses to its first-in-class targeted oncology therapies, reported that Laura Benjamin, Ph.D., Founder and CEO of OncXerna, will present at the LifeSci Partners Private Company Summer Symposium taking place virtually from July 21-23, 2021 (Press release, OncXerna Therapeutics, JUL 19, 2021, View Source [SID1234584944]). Please click the following link to register for the event: Register Here

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Neurocrine Biosciences Announces Conference Call and Webcast of Second Quarter 2021 Financial Results

On July 19, 2021 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that it will report second quarter 2021 financial results after the Nasdaq market closes on Tuesday, August 3, 2021 (Press release, Neurocrine Biosciences, JUL 19, 2021, View Source [SID1234584943]). Neurocrine will then host a conference call and webcast to discuss its financial results and provide a company update that day at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Participants can access the live conference call by dialing 866-952-8559 (US) or 785-424-1743 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine’s website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

Lonza and CN Bio announce distribution agreement providing prevalidated hepatocytes for use on innovative organ-on-a-chip range

On July 19, 2021 Lonza and CN Bio reported that thay have entered into a distribution agreement whereby Lonza will supply a selection of hepatic cells to be prequalified by CN Bio for use in their PhysioMimix Single-and Multi-Organ MPS to transform the way human-relevant pre-clinical data is generated (Press release, Lifescience Newswire, JUL 19, 2021, View Source [SID1234584942]). With prequalified cells, customers can avoid having to trial numerous cell types in order to be assured of finding ones that will grow and behave functionally in 3D culture and fast-track their route to generating reliable and robust data.

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The use of physiologically relevant in vitro models plays an important role in driving down attrition rates and boosting the efficiency and success of drug discovery programs. It is increasingly clear that standard 2D cell culture fails to accurately reflect the complex interactions that take place in the living body, while animal models are slow, expensive and don’t always correlate to the same interactions in humans. Innovative models, such as OOC, offer the way forward and this agreement is a critical step in realizing that vision to bring more physiologically relevant models to the industry.

Maureen Bunger, Senior Product Manager, ADME-Tox Solutions, Lonza Cell and Gene, commented: "Today’s drug discovery success is hugely dependent on performing experiments using the right biological model to best reflect in vivo environments. This new agreement with CN Bio further demonstrates Lonza’s commitment to supporting innovation and to the development of the most advanced cell models for enhanced drug discovery and development success."

The PhysioMimix Single and Multi-Organ MPS allow researchers to recreate an environment that more accurately represents the human body in the laboratory to generate translationally relevant pre-clinical data. Until now, the widespread adoption of OOC technologies has been hampered by a lack of quality control and performance criteria for consistent use of the devices and reproducibility of results between experimental sites. These have posed significant limitations for translational experiments using OOC technology in contexts of use in drug development. To address this, the FDA has worked with CN Bio to demonstrate the robustness and reliability of their technology for drug metabolism and safety toxicity applications.

Dr. Tomasz Kostrzewski, Director of Biology, CN Bio, commented: "We’re delighted to be working with Lonza, a world-leading cell supplier, to ensure that the prevalidated cells we supply for use with our PhysioMimix Single-and Multi-Organ MPS are of reliably high quality and are well-suited to culture in 3D. Using prequalified cells will save our customers valuable time and resource, further helping to accelerate their drug development journey."

Lonza hepatocyte cells meet the high standard of quality required by organ-on-a-chip systems. With a robust manufacturing process and excellent quality control, state-of-the-art facilities and Lonza’s decades of specialist experience and deep expertise, Lonza cells offer a greater chance of reproducible success. Access to a wide variety of large-sized lots gives customers confidence in ongoing cell availability.